MEMORANDUM OF UNDERSTANDING
BETWEEN U.S. DEPARTMENT OF HEALTHAND HUMAN SERVICES
THE FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL POLICY
AND THE REGENTS OF THE UNIVERSITY OF MINNESOTA
The Food and Drug Administration (FDA) and the Regents of the University of Minnesota (UM) share interests in promoting scientific progress through exchange of scientific capital in the areas of public health and regulatory research. Both institutions foresee benefits from the mutual exchange of training and research expertise that will enhance the regulatory review and post-marketing surveillance processes at the FDA. This Memorandum of Understanding (MOU) establishes the terms for collaboration to promote these shared interests, which can be pursued through various programs including collaborative education and research.
FDA is authorized to enforce the Federal Food, Drug, and Cosmetic Act (the Act). In fulfilling its responsibilities under the Act, FDA, among other things, directs its activities toward promoting and protecting the public health by assuring the safety, efficacy, and security of drugs, veterinary products, medical devices and radiological products and the safety and security of foods, dietary supplements, and cosmetics, and for regulating tobacco products. To accomplish its mission, FDA must stay abreast of the latest developments in research and communicate with stakeholders about complex scientific and public health issues. Increased development of research, education and outreach partnerships with UM will contribute to FDA’s mission.
UM is one of the world's most important centers of research and at the same time is a distinctive and distinguished site of learning for undergraduates and graduate students in many fields, including public health and medical research. It seeks to attract a diverse and international faculty and student body, to support research and teaching on global issues, and to create academic relationships with many countries and regions. It expects all areas of the university to advance knowledge and learning at the highest level and to convey the products of its efforts to the world.
III. Substance of Agreement
This MOU forms the basis for development of scientific collaborations, outreach and educational initiatives and intellectual partnerships between FDA and UM. The types of initiatives expected to develop from this MOU include:
a. Advancing student education in public health by expanding existing programs to include important topics relevant to medical product regulation and research. One of the mechanisms to enroll students, post-doctoral trainees and residents from UM into the joint fellowship program at the FDA is through the Center for Drug Evaluation and Research (CDER) Oak Ridge Institute for Science and Education (ORISE) fellowship program. Faculty sabbatical may be covered under ORISE if applicable. If prospective fellows or faculty members enter the program through the ORISE Fellowship program mechanism, CDER and UM will adhere to the CDER ORISE Fellowship rules. Fellows or faculty members entering the program must agree to adhere to the term of appointment which will be outlined in an offer of appointment letter.
b. Opportunities for FDA staff to serve as adjunct UM faculty or on UM advisory boards;
c. Opportunities for UM faculty to serve as visiting scientists at FDA;
d. Opportunities to convene joint meetings for education and research; and
e. Opportunities for UM faculty and graduate students and FDA scientists to engage in research collaborations.
Under this MOU, joint efforts will be undertaken to obtain extramural funds to support collaborative research and training as permitted under appropriate statutory authority. Before any specific collaboration is initiated or implemented, the Parties shall identify priorities, topics of mutual interest; and develop separate, written agreements of collaboration and sharing of resources. Where applicable, these agreements shall incorporate by reference this MOU. FDA may enter additional agreements with UM to the extent authorized by law and available appropriations. The terms and conditions of any such awards will comply with applicable federal law and regulations.
IV. General Provisions
1. Rights to any inventions resulting from collaborative research will be determined by separate written research agreements governing the effort, based on current U.S. Government patent regulations and any other applicable statutes and regulations.
2. Institutions within the UM and FDA may decide to enter Cooperative Research and Development Agreements (CRADA) specific to particular collaborative projects. The terms of such CRADAs will address Intellectual Property rights.
3. Proprietary and/or non-public information will not be disclosed under this MOU, unless such disclosure is governed by appropriate confidentiality disclosure agreements or to the extent such disclosure is permitted by law.
4. Each-Party will comply with the other Party's security procedures and policies regarding access to and use of facilities. Either Party may restrict or limit access to its property and facilities at any time and for any reason. UM individuals participating in activities under this MOU on FDA property will comply with all applicable federal statutes and regulations.
V. Resource Obligations
This MOU represents the broad outline of how FDA and UM intend to collaborate in areas of mutual interest. It does not create binding, enforceable obligations against any Party. All activities that may be undertaken by this MOU are subject to available personnel, resources, and funds. This MOU does not affect or supersede any existing or future agreements or arrangements among the Parties and does not affect the ability of the Parties to enter other agreements or arrangements related to this MOU.
VI. Liaison Officers
FDA’s CDER is the lead center for this MOU. The individual to whom all inquiries to FDA should be addressed is:
Senior Project Management Officer
10903 New Hampshire Ave
Bldg. 51 Room 2212
Silver Spring, MD 20993
Tel: (301) 796-0381
Fax: (301) 847-3529
The individual to whom all inquiries to UM should be addressed is:
University of Minnesota Sponsored Projects Administration
450 McNamara Alumni Center
200 Oak St SE
Minneapolis, MN 55455
Tel: (612) 625-0571
Fax: (612) 624-4843
Each Party may designate new liaisons by notifying the other Party's administrative liaison in writing. If an individual designated as a liaison under this agreement becomes unavailable to fulfill those functions, the Parties will name a new liaison within 2 weeks and notify the other Party through the designated administrative liaison.
VII. Term, Termination, and Modification
This agreement becomes effective upon acceptance by both Parties and will continue in effect for five (5) years. It may be renewed by mutual written agreement of both Parties. It may be modified by mutual written agreement of both Parties. It may be terminated by either Party upon 60-day advance written notice to the other.
VIII. Statutes, Regulations, Rules, and Policies
This MOU and all associated agreements will be subject to the applicable statutes, regulations, rules, and policies under which FDA, UM and the institutions within UM operate.
Approved and Accepted
for the Food and Drug Administration
Janet Woodcock, MD
Center for Drug Evaluation and Research Food and Drug Administration
August 26, 2014
Approved and Accepted
for the Regents of the University of Minnesota
University of Minnesota
September 4, 2014